Long-term Safety Study of the GORE® HELEX® Septal Occluder

Not Applicable

Completed

• Conditions: Septal Defect, Atrial
• Interventions: Device: GORE® HELEX® Septal Occluder

• Registration Number: NCT00581308
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).

Detailed Description

The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of Approval Study. All subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2009-10
• Results First Submitted: 2012-01-04
• Results First Submitted QC: 2012-01-04
• Results First Posted: 2012-02-07
• Study Completion: 2014-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• ASD less than or equal to 18 mm.

Exclusion Criteria

• Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
• Unable to accommodate device delivery catheter.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GORE® HELEX® Septal Occluder	GORE® HELEX® Septal Occluder	Subjects who received a GORE® HELEX® Septal Occluder

Primary Outcome Measures

Name	Time	Method
Efficacy	60 months	A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure.; Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of: * Any major device/procedure adverse event; * Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.; * Clinically significant leak at the follow-up visit
Safety	5 years	A calculation of the proportion of subjects experiencing one or more major device or procedure related adverse event(s) at 1, 2, 3, 4, and 5 years post procedure.

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States